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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Attendee Presentations
2017 PDA/FDA Joint Regulatory Conference
Program Agenda
(?)
Peter W Marks, MD, PhD
P1: Welcome and Opening Plenary Session
(?)
Rosemarie Hunziker, PhD - NEW
P1: Welcome and Opening Plenary Session
(?)
Guy Villax - NEW
P2: Current Quality Challenges for Pharmaceutical Executives
(?)
John R Pinion, II
P2: Current Quality Challenges for Pharmaceutical Executives
(?)
Carmelo Rosa, PsyD - NEW
A1: Data Integrity
(?)
Cormac Dalton, PhD
A1: Data Integrity
(?)
Kevin Cloonan
B1: Quality Systems: Maturity Models and Continuous Improvement
(?)
Brooke K Higgins, MS - NEW
B1: Quality Systems: Maturity Models and Continuous Improvement
(?)
Earl Dye, PhD
C1: Expedited Pathways: Developing a Quality Product under Accelerated Timelines
(?)
Sau (Larry) Lee, PhD
C1: Expedited Pathways: Developing a Quality Product under Accelerated Timelines
(?)
Thomas Friedli
A2: Quality Culture and Enabling Lifecycle Quality Improvement
(?)
Cylia Chen-Ooi - NEW
A2: Quality Culture and Enabling Lifecycle Quality Improvement
(?)
Ashley B Boam, MSBE and Andrew C. Chang, PhD
B2: ICH Q12 Change Management and Risk Management
(?)
Nina Bauer_PhD, MBA - NEW
C2: Advanced Therapies
(?)
Deborah A Hursh, PhD
C2: Advanced Therapies
(?)
Linda S Kramer, MS-NEW
IG1: Vaccines
(?)
Lucy Cabral, Amelia Mutere, MS, Lisa Milano-NEW
IG3: Supply Chain Management
(?)
Donald E Hill, PE
BR1: Practical Guidance on How to Conduct and Evaluate an Effective Smoke Study
(?)
Kara Follman, PhD - NEW
BR2: Best Practices for CMC NDA Supplement Submissions
(?)
LCDR James Coburn - NEW
BR3: 3D Printing in the Advancement of Medicine
(?)
Linda J Ricci - NEW
BR4: Digital Health
(?)
Valerie Whelan
A3: Quality Metrics
(?)
Susan Batcha
B3: Lifecycle Management of a Legacy Biotechnology Process
(?)
Peter Turecek, PhD-UPDATED
B3: Lifecycle Management of a Legacy Biotechnology Process
(?)
Francis Godwin, MBA-UPDATED
C3: Compliance and Enforcement Trends
(?)
Robert D McElwain
C3: Compliance and Enforcement Trends
(?)
Paula Katz, JD - NEW
A4: Overseeing Your Supply Chain
(?)
Zena G Kaufman
A4: Overseeing Your Supply Chain
(?)
Theresa M Mullin, PhD-UPDATED
B4: Center International Affairs Leaders Discuss the Global Reach of FDA
(?)
Joan W Blair, MA
B4: Center International Affairs Leaders Discuss the Global Reach of FDA
(?)
Alonza E Cruse - NEW
A5: FDA Program Alignment
(?)
Arleen Paulino
B5: Advances in Manufacturing of Biological Products
(?)
Patricia F HughesTroost,PhD
B5: Advances in Manufacturing of Biological Products
(?)
Shannon M Hoste, MS, RAC and Rita L Lin, MS
C5: Regulatory Considerations
(?)
John Towns, PhD
C5: Regulatory Considerations
(?)
C Carter, D Gulati, JD Doleski-NEW
IG7: Inspection Trends
(?)
LCDR QuynhNhu T Nguyen, MS
C5: Regulatory Considerations
(?)
Rebecca E Dombrowski - NEW
BR5: Process Validation of Sterile Products
(?)
Marsha Steed (Hardiman) - NEW
BR7: Microbiology Laboratory Controls
(?)
Pallavi Nithyanandan, PhD
BR8: Role of Standards in the Pharmaceutical Industry
(?)
Gary L Hoffman, MS - NEW
BR9: Bridging Cultures in Pharmaceutical Development and Manufacturing
(?)
Carl Fischer, PhD-NEW
P4: Center Updates
(?)
Donald D Ashley, JD-UPDATED
P5: Compliance Update and Closing Remarks
(?)
Carl Fischer, PhD
P5: Compliance Update and Closing Remarks
(?)
Martine L Hartogensis, DVM
P5: Compliance Update and Closing Remarks
(?)
Mary A Malarkey
P5: Compliance Update and Closing Remarks
(?)
Douglas W Stearn, JD-NEW
P5: Compliance Update and Closing RemarksP5: Compliance Update and Closing Remarks
(?)
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